What is the mechanism of action of this treatment?

Common treatments for healthy subjects often include physical activity and exercise, which work by enhancing cardiovascular health, improving muscle strength, and increasing flexibility. These activities stimulate neuroplasticity, improve balance, and enhance overall physical function. The microprocessor-controlled treadmill, which delivers controlled postural disturbances, specifically targets balance and coordination by challenging the body's stability mechanisms. This is particularly important for healthy subjects as it can prevent falls, improve proprioception, and maintain functional independence.

What side effects are associated with this type of intervention?

Common treatments for postural control and balance, such as those involving controlled postural disturbances, may include physical therapy, balance exercises, and the use of specialized equipment like treadmills. Known side effects of these treatments can include muscle fatigue, discomfort in various body regions, and increased energy expenditure. In some cases, there may be temporary dizziness or imbalance as the body adjusts to the interventions.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned for treatments in healthy subjects related to controlled postural disturbances using a microprocessor-controlled treadmill. Generally, FDA approvals for treatments in healthy subjects are rare, as most approvals focus on treating specific conditions or diseases. However, treatments that improve general health, such as vaccines, nutritional supplements, and preventive medications, are sometimes approved for use in healthy populations.

What other types of research exist?

Promising alternatives to microprocessor-controlled treadmills for controlled postural disturbances include: 1) Exoskeletons with sensor-driven finite state machines (FSM) for stepping, which can adjust to individual needs and coordinate muscle activation. 2) Myoelectric controllers for multigrasp prosthetic hands, which offer advanced postural control schemes. 3) Inertial sensor technology integrated with balance tests, such as the Y Balance Test (YBT), to capture subtle alterations in motor function and dynamic balance control.

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Device

Treadmetrix Validation for Balance Assessment

N/A

Waitlist Available

Led By Kenton Kaufman, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy adults with no medical conditions or previous injuries, trauma, or surgeries that reduce balance, mobility, or strength

Be between 18 and 65 years old

Must not have

Current or chronic pain in shoulders, elbows, hips, knees, ankles, feet, neck, or back

Use of assistive device such as walker or cane

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of participant test session (approximately 2 hours)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special treadmill that uses a computer to control its movements. It is likely aimed at people who need to test or improve their balance. The treadmill creates specific movements to see how well someone can stay balanced.

Who is the study for?

This trial is for healthy adults who can follow instructions and have no medical conditions, injuries, or surgeries affecting balance, mobility, or strength. There are no restrictions based on gender, race, or ethnicity. People with chronic pain in major joints or the back or those using assistive devices like walkers cannot participate.

What is being tested?

The study is testing 'Treadmetrix', a microprocessor-controlled treadmill designed to deliver controlled postural disturbances. The goal is to validate how accurately this equipment can simulate these disturbances for research purposes.

What are the potential side effects?

Since this trial involves physical activity on a treadmill that simulates disturbances in posture, potential side effects may include muscle soreness, fatigue, and risk of falls during the test.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a healthy adult with no conditions or past injuries affecting my balance, mobility, or strength.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have ongoing pain in my joints or back.

Select...

I use a walker or cane for mobility.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of participant test session (approximately 2 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of participant test session (approximately 2 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of participant test session (approximately 2 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Estimate the limits of agreement between observed and commanded treadmill belt disturbance parameters: average initial acceleration.

Estimate the limits of agreement between observed and commanded treadmill belt disturbance parameters: belt displacement.

Estimate the limits of agreement between observed and commanded treadmill belt disturbance parameters: peak velocity.

Secondary study objectives

Kinetic loading exerted on treadmill during perturbations: treadmill force.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Balance assessment on specialized treadmillExperimental Treatment1 Intervention

Subjects will undergo a balance assessment on a microprocessor-controlled treadmill

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for healthy subjects often include physical activity and exercise, which work by enhancing cardiovascular health, improving muscle strength, and increasing flexibility. These activities stimulate neuroplasticity, improve balance, and enhance overall physical function. The microprocessor-controlled treadmill, which delivers controlled postural disturbances, specifically targets balance and coordination by challenging the body's stability mechanisms. This is particularly important for healthy subjects as it can prevent falls, improve proprioception, and maintain functional independence.

Vestibular and balance rehabilitation therapy.The Effect of Walking Intervention on Cognitive Function Among Patients With Non-Central Nervous System Cancer: A Systematic Review.Effectiveness of instrument-assisted soft tissue mobilization for the management of upper body, lower body, and spinal conditions. An updated systematic review with meta-analyses.